Kornimate/medical-research-clean huggingface dataset:
impact of a physical exercise program in a rural area

Conditions: Old Age; Debility

Summary: with this work we want to assess whether there are differences in the amount of physical activity per week, measured by accelerometry in 3 groups of subjects, where one group (g1) has been carrying out a pa program called "enguera sé saludable" for a year. another group (g2) newly introduced to the same exercise program, and a control group (g3) that does not carry out an exercise program but declared itself active.

active aging, according to the world health organization (who), involves making the most of everything that contributes to physical, mental and social well-being throughout life, thus promoting improved quality of life, functionality and longevity in the most advanced stages of life, seeking to minimize disability. to achieve active aging, older people must remain active in all aspects: physical, social and mental. for this reason, the who recommends that older adults engage in moderate to vigorous physical activity (mvpa) of 150 minutes a week the objetive, to assess whether there are differences in the amount of mvpa per week, measured by accelerometry in 3 groups of subjects, where one group (g1) had been carrying out a pa program called "enguera sé saludable" for a year, another group (g2 ) newly inserted into the same exercise program, and a control group (g3) that did not carry out an exercise program but declared itself active. analytical quasi-experimental study, with 3 groups. a group (g1) over 59 years of age, of both sexes who have been doing pa since the year before the start of the study, within the "enguera be healthy" program in the municipality of enguera. another group (g2) of both sexes, newly enrolled in the same exercise program over 59 years of age. a control group (g3) of 59 years of both sexes who do not carry out the exercise program, inhabitants of enguera and apparently active. the data analyzed was obtained from the placement of an actigraph model gt3x bt accelerometer for a week and the collection of data from the various instruments such as the measurement of blood pressure and weight using the tanita bc scale. -545n, the tinetti scale, the time up \& go test, the monopodal test, the sppb test, the sit to stand test, the borg scale, the ipaq questionnaire and the fhsq questionnaire.

Eligibility criteria:
inclusion criteria: * adults over 59 years of age. * patients who comply with accelerometer times for 7 days. * patients who correctly complete the accelerometer registration sheet. * patients who complete the informed consent exclusion criteria: * patients who do not wear the accelerometer 600 minutes a day for at least 3 days on weekdays and 480 minutes for at least 1 day on the weekend. * patients who suffer from illness during data collection. * patients who do not wear the accelerometer for 7 days. be in ipaq category 1 (low level of af).

Keywords: old adults exercise accelerometry
meropenem plasma concentration measurements at the pediatric medical ward, oslo university hospital, rikshospitalet

Conditions: Bacterial Infection

Summary: the object of the study is to investigate whether all included patients receive treatment that is effective against all bacteria that are defined as sensitive to meropenem with the current treatment regimen. will the investigators findings motivate routine monitoring of plasma concentrations in children receiving meropenem? up to 50 patients will be included in the study, and all participants are children.


Eligibility criteria:
inclusion criteria: * children aged from 3 months to 18 years that receive treatment with meropenem. inclusion is independent of how long the patient has been receiving treatment. children receiving other treatment (except hemodialysis)/other medications can be included. exclusion criteria: * children less than three months of age. patients receiving hemodialysis. lack of consent.

Keywords: meropenem child bacterial infection treatment evaluation
a study to examine the progression of attention-deficit hyperactivity disorder (adhd) drug treatment and to analyze associated factors

Conditions: Attention-deficit Hyperactivity Disorder

Summary: the purpose of this observational study is to explore the efficacy of methylphenidate hydrochloride in children and adolescents diagnosed with attention-deficit hyperactivity disorder (adhd) by kiddie-scheduled for affective disorders (sads)-present and life time version (k-sads-pl).

this is a 1-year open-label (all people involved know the identity of the assigned drug), multicenter, single arm, prospective, observational study to explore under natural setting the efficacy of drug treatment in children and adolescents diagnosed with adhd by k-sads-pl (k-sads-pl is a tool used for adhd diagnosis. patient may be diagnosed with adhd by using k-sads-pl to check if he or she meets the criteria according to diagnostic and statistical manual of mental disorders \& edition (dsm-iv). after obtaining informed consent, investigator will prescribe stimulant or non-stimulant adhd treatment medications (ie, immediate release \[ir\]/extended release \[er\]/osmotic release oral system (oros) methylphenidate, atomoxetine). efficacy and safety assessments will be performed at 4, 12, 24, 36, and 52 weeks after the first day of giving study drug. progression of symptom improvement and adherence will be investigated and associated variables (ie, demographic, clinical, familial and treatment factors) will be analyzed.

Eligibility criteria:
inclusion criteria: * has been diagnosed with attention-deficit hyperactivity disorder (adhd) by kiddie-sads-present and life time version (k-sads-pl) * have not received methylphenidate or atomoxetine within 3 months prior to screening. exclusion criteria: * has intelligence quotient (iq) ≤70 assessed by comprehensive attention test (cat) at screening diagnosed with congenital disorders * has had history of acquired brain damage (eg, cerebral palsy) * has had diagnosed with convulsive disabilities or other neurological disease or dysesthesia * has had developmental disabilities such as autistic spectrum disorder * has had history of schizophrenia, bipolar, or other pediatric psychotic disorder, and obsessive compulsive disorder * has had linguistic disability and had diagnosed with tic disorder that requires additional drug treatment.

Keywords: attention-deficit hyperactivity disorder developmental disorder atomoxetine methylphenidate psychiatric disorder
a trial comparing the efficacy and tolerability of faslodex with nolvadex in postmenopausal women with advanced breast cancer

Conditions: Breast Cancer; Metastasis

Summary: the purpose of this study is to compare the efficacy of faslodex (fulvestrant) to nolvadex (tamoxifen) as first-line treatment for postmenopausal women with advanced breast cancer. patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.


Eligibility criteria:
inclusion criteria: * biopsy confirmation of breast cancer. evidence of breast cancer that is not considered amenable to curative treatment. postmenopausal women. written informed consent to participate in the study. exclusion criteria: * previous treatment with hormonal therapy unless that therapy was tamoxifen for adjuvant breast cancer. the use of tamoxifen must have ceased at least one year before this study. previous treatment with faslodex. any existing serious disease, illness, or condition that will prevent participation or compliance with the study procedures. treatment with an investigational or non-approved drug within one month of then start of the study.

Keywords: locally advanced breast cancer or metastatic breast cancer
facial yoga toning program - a pilot study

Conditions: Facial Atrophy Related to Age

Summary: the primary objective of this study is to determine the efficacy of a facial yoga exercise program on appearance and to measure patient satisfaction with facial yoga practice.

this is a single center prospective longitudinal pilot study of 27 subjects. the study will include 20 study subjects and 7 controls. participants in this study will be healthy subjects 18 years and older with mild to moderate facial atrophy without a history of surgical or non-surgical treatment to the area. the study subjects will perform facial yoga and apply sunscreen (neutrogena helioplex spf 55) daily. the controls will apply sunscreen alone daily for 8 weeks.

Eligibility criteria:
inclusion criteria: * over age 18 years exclusion criteria: * pregnancy
phase 2a study of iw-6463 in adults diagnosed with mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes (melas)

Conditions: MELAS

Summary: this is a single-arm study to evaluate safety and tolerability of oral iw-6463 in adults diagnosed with melas.

iw-6463 tablets will be orally administered once-daily (qd) for up to 29 days

Eligibility criteria:
inclusion criteria: 1. prior genetic confirmation of a known mitochondrial disease mutation 2. neurological features of melas (can be based on medical history) 3. elevated plasma lactate levels at screening visit (≥1.0 mmol/l) 4. women of childbearing potential must have a negative pregnancy test prior to randomization and must agree to use protocol-specified contraception from the screening visit through 90 days after the final dose of study drug. 5. male participants must be surgically sterile by vasectomy (conducted ≥60 days before the screening visit or confirmed via sperm analysis) or must agree to use protocol-specified contraception and agree to refrain from sperm donation from the screening visit through 90 days after the final dose of study drug. 6. other inclusion criteria per protocol exclusion criteria: 1. positive pregnancy test at screening or on day 1 2. hypotension defined as systolic blood pressure (bp) ≤90 mmhg or diastolic bp ≤60 mmhg at screening or predose at day 1 3. hypertension defined as systolic bp \>160 mmhg or diastolic bp \>100 mmhg, at screening or predose at day 1 4. uncontrolled diabetes 5. severe gastrointestinal dysmotility as determined by the investigator that may impact compliance and/or oral drug administration, absorption and exposure. 6. unable to fast for 3-4 hours after a meal 7. unable or unwilling to adhere to the study schedule, lifestyle restrictions, assessment requirements or, in the clinical judgment of the investigator, is otherwise not suitable for study participation. 8. current or past history of clinically significant cardiomyopathy and/or cardiac conduction abnormality 9. used any nicotine-containing products (eg, cigarettes, e-cigarettes, vape pens, cigars) within 1 month of enrollment 10. other exclusion criteria per protocol

Keywords: mitochondrial disease
vaccine therapy plus qs21 in treating patients with small cell lung cancer that has responded to initial therapy

Conditions: Lung Cancer

Summary: rationale: vaccines may make the body build an immune response to kill tumor cells. biological therapies, such as qs21, use different ways to stimulate the immune system and stop cancer cells from growing. purpose: phase ii trial to study the effectiveness of vaccine therapy plus qs21 in treating patients who have small cell lung cancer that has responded to initial therapy.

objectives: i. compare the antibody response after immunization with polysialic acid keyhole limpet hemocyanin (psa-klh) conjugate or n-propionylated psa-klh conjugate plus immunological adjuvant qs21 in patients with small cell lung cancer. ii. assess the clinical toxicities resulting from these regimens and from the immune response in this patient population. outline: patients receive polysialic acid keyhole limpet hemocyanin (psa-klh) conjugate or n-propionylated psa-klh conjugate plus immunological adjuvant qs21 subcutaneously weekly on weeks 1-4 and on weeks 8 and 16 for a total of 6 vaccinations. patients are followed at 2 weeks, and then every 3 months for up to 1 year. projected accrual: a total of 12 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically confirmed small cell lung cancer must have completed initial therapy with or without radiotherapy and have achieved a complete response or partial response to therapy without subsequent evidence of disease progression must have completed any radiotherapy including prophylactic cranial radiotherapy as part of the planned primary therapy patient characteristics: age: 18 and over performance status: karnofsky 70-100% life expectancy: not specified hematopoietic: wbc at least 3,000/mm3 lymphocyte count at least 500/mm3 hepatic: bilirubin no greater than 1.5 mg/dl sgot no greater than 1.5 times upper limit of normal (uln) alkaline phosphatase no greater than 1.5 times uln renal: not specified cardiovascular: no new york heart association class iii or iv heart disease other: no known immunodeficiency or autoimmune disease no other active malignancies within the past 5 years except nonmelanoma skin cancer no clinically significant peripheral neuropathy not pregnant or nursing negative pregnancy test fertile patients must use effective contraception prior concurrent therapy: biologic therapy: see disease characteristics at least 4 weeks but no more than 12 weeks since prior initial therapy and recovered chemotherapy: see disease characteristics at least 4 weeks but no more than 12 weeks since prior initial therapy and recovered endocrine therapy: see disease characteristics at least 4 weeks but no more than 12 weeks since prior initial therapy and recovered no concurrent corticosteroids radiotherapy: see disease characteristics at least 4 weeks but no more than 12 weeks since prior initial therapy and recovered no prior radiotherapy to the spleen surgery: no prior splenectomy

Keywords: limited stage small cell lung cancer
neutral versus liberal fluid in traumatic brain injury: a randomised controlled trial

Conditions: Traumatic Brain Injury; Fluid Overload; Outcome, Fatal

Summary: feasibility and safety of targeting neutral vs liberal fluid balance in traumatic brain injured patients: a phase ii randomized controlled trial

to determine whether a zero fluid balance strategy during the first week compared to a more liberal fluid policy (allowing positive balance) is feasible in adult intensive care unit (icu) patients with traumatic brain injury (tbi).participants randomized to neutral fluid balance will be assessed daily with the aim to maintain a mean daily fluid balance of 0 over the course of the first 5 days from randomization (maximum at day 7 of icu stay). in case of need for augmentation of cerebral perfusion pressure with 0 balance, fluids will be allowed according to a predefined protocol (see further).participants randomized to the control group will receive the standard fluid management required as determined by the treating team. fluid strategy as randomised should be applied for at least 5 days from randomization. primary aim: ● feasibility: ability to achieve a daily neutral balance (0 +/- 500 ml) in the intervention group. secondary aims:● incidence of renal complications, including acute kidney injury, need for renal replacement, multiorgan failure * respiratory complications including reduced partial pressure of oxygen/ fraction of inspired oxygen (p/f) ratio * cardiopulmonary complications, i.e myocardial infarction, cardiac failure, cardiac arrhythmias, ventricular or supraventricular, pulmonary oedema, ventilator associated pneumonia, acute respiratory distress syndrome * difference in mean and daily cpp among the groups * difference in daily fluid balance and fluid input during the first 7 days after icu admission * total and daily dose of vasopressors and diuretics during icu stay * vasopressor-free days up to 28 days from icu admission * icu-free days up to 28 days * ventilator-free days up to 28 days from intubation. * maximum therapy intensity level (til) during the 5 days of randomization

Eligibility criteria:
inclusion criteria: * adult patients with tbi (isolated or with extracranial injuries, with and without icp monitoring) * admitted to intensive care unit * age \>18 years * enrolment \<48h after icu admission exclusion criteria: * enrolled in another clinical trial that is unapproved for co-enrolment * pregnant or suspected pregnancy * concomitant hemorrhagic shock expected to require surgical treatment in the following 24h from inclusion or requiring polytransfusions (\> 6 blood products or massive transfusion protocol) * hemodynamic instability (hr \> 120 despite fluid resuscitation of at least 1 liter, and systolic blood pressure \ 0.5 mcg/kg/min) or inotropes (any dose)
confirming the effectiveness of online guided self-help family-based treatment for adolescent anorexia nervosa

Conditions: Anorexia Nervosa

Summary: with an incidence rate of about 1%, anorexia nervosa (an) is a serious mental disorder associated with high mortality, morbidity, and cost. an in youth is more responsive to early treatment but becomes highly resistant once it has taken an enduring course. the first-line treatment for adolescents with an is family based treatment (fbt). while fbt can be delivered using videoconferencing (fbt-v), therapists' limited availability hampers scalability. guided self-help (gsh) versions of efficacious treatments have been used to scale and increase access to care. the main aim of this proposed comparative effectiveness study is to confirm that clinical improvements in gsh-fbt are achieved with greater efficiency than fbt-v in generalizable clinical settings.


Eligibility criteria:
inclusion criteria: 1. participants are 12-18 years of age 2. participants live with a family (some families may contain only one parent) 3. family members fluently speak and read english and have access to a computer with internet 4. participants meet dsm-5 criteria for an (both subtypes) 5. ebw above 75% 6. participants are medically stable for outpatient treatment according to the recommended thresholds of the american academy of pediatrics and the society of adolescent medicine 7. participants are not engaged in another individual or family-based psychotherapy trial during the duration of treatment sessions in the study. 8. medications for comorbid psychiatric disorders are ok; randomization will balance groups through tracking. exclusion criteria: current psychotic illness or intellectual disability or other mental illnesses that would prohibit the use of psychotherapy; current dependence on drugs or alcohol; physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight; previous fbt; and inability of the participant and/or family to speak and understand english.
right ventricular defibrillation lead select site study

Conditions: Heart Failure, Congestive; Tachycardia, Ventricular

Summary: this study will compare single coil right ventricular defibrillation leads for implanted cardioverter/defibrillators (icds) in the apical and high septal locations. it is hypothesized that rv septal positions are at least as good as apical positions using formally measured defibrillation thresholds(dfts), and that they may have long term advantages in reducing left ventricular dysfunction.

the new studies "right ventricular lead/select site registry" and "right ventricular lead/select site registry: acute study" are studies designed to look at alternate lead locations for defibrillation leads for icds. the registry is designed to capture data from patients who have already undergone implant, so as to be able to publish long term data on defibrillation thresholds, pacing thresholds and left ventricular function. this will include both patients from the acute study, and those patients in whom leads have already been placed, and the exact lead location is known. the acute study is designed to directly compare defibrillation thresholds in the apical location versus the interventricular septal location for defibrillation leads. this study involves a direct comparison of two different sites in the same patient; using defined criteria for implant location (see protocol). the acute study is anticipated to enroll 34 patients, but the registry to collect ongoing data will be larger, encompassing previously implanted patients, with an expected sample size of 61 total in the registry for data collection.

Eligibility criteria:
inclusion criteria: * standard indications for icd placement (aha/acc guidelines) exclusion criteria: * inability to consent * age less than 21 years * inability to participate in study follow-up

Keywords: implanted cardioverter defibrillator congestive heart failure right ventricular lead placement select site pacing
a diabetes study to treat a population previously not at target

Conditions: Type 2 Diabetes

Summary: this study will assess if customizing the start dose of rosuvastatin appropriate for the degree of ldl-c reduction required, would achieve ldl-c target of ≤ 2.0 mmol/l quickly with either no titration or just one titration step after 6 weeks of therapy in type 2 diabetic patients previously treated with another statin and not at ldl-c targets.


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes * previously treated with a commonly accepted start dose of a statin for the last 4 weeks prior to study entry * fasting ldl-c concentration of \> 2.0 mmol/l (and ≤ 5.0 mmol/l) (in the past 3 months) * history of serum tg level of ≤ 4.6 mmol/l (in the past 3 months) exclusion criteria: * if currently receiving therapy with any statin at a dose higher than listed * rosuvastatin (current use) * fibrates, niacin or resins that was not discontinued a minimum of 2 months prior to enrolment. * type 1 diabetes; glycated haemoglobin (hba1c) \> 9.0% * alanine aminotransferase (alt) or aspartate aminotransferase (ast) level ≥ 1.5 × upper limit of normal (uln) (in the past 2 months) * resting diastolic or systolic blood pressure of \> 95 mmhg or \> 180 mmhg, respectively (in the past 2 months) * unexplained serum creatine kinase (ck) level \> 3 × uln (in the past 2 months).

Keywords: diabetes type 2
biomarker in tissue samples from patients with ewing sarcoma

Conditions: Sarcoma

Summary: rationale: studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research trial studies biomarkers in tissue samples from patients with ewing sarcoma.

objectives: * to determine the frequency of ini-1 protein loss in ewing sarcoma. outline: previously collected tissue samples are analyzed for ini-1 protein loss by ihc and tissue microarray.

Eligibility criteria:
disease characteristics: * diagnosis of ewing sarcoma * prepared tissue microarray with ewing sarcoma samples available patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: ewing sarcoma/peripheral primitive neuroectodermal tumor (pnet)
a study of plant-based diet on postprandial sleepiness

Conditions: Drowsiness

Summary: this research aims to develop a better understanding and clinical knowledge of the effects of a plant-based diet on postprandial sleepiness.


Eligibility criteria:
inclusion criteria * sleepiness after eating lunch. * ess score ≥3 for answering the question about these two situations: 'sitting quietly after lunch without alcohol' and 'lying down to rest in the afternoon when circumstances permit'. exclusion criteria * diabetes. * pregnancy or lactation. * current use of a vegan/plant-based diet * bmi ≤ 22. * iron deficiency. * vitamin b12 deficiency.

Keywords: postprandial sleepiness